Telemedicine Follow-up for Post-ACS Patients

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04485754

Collaborator

(none)

Enrollment

Location

Arms

19.5

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients

Condition or Disease	Intervention/Treatment	Phase
ACS - Acute Coronary Syndrome	Other: Telemedicine FU Other: Office FU	N/A

Detailed Description

Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients

Actual Study Start Date :

May 15, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemedicine FU Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.	Other: Telemedicine FU Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
Active Comparator: Office FU Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.	Other: Office FU Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Arm

Intervention/Treatment

Experimental: Telemedicine FU

Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Other: Telemedicine FU

Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Active Comparator: Office FU

Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Other: Office FU

Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

Outcome Measures

Primary Outcome Measures

MACCE [1 year]
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke

Secondary Outcome Measures

High level of MT optimization [1 year]
High Level of Medical Therapy Optimization is defined as a participant meeting all of the following goals: LDL < 1.4 mmol/L and on any statin, blood pressure < 140/90 mm/Hg (<135/85 mm/Hg for patients with diabetes mellitus), on aspirin or other antiplatelet or anticoagulant, and not smoking. High level of medical therapy optimization is missing if any of the individual goals are missing.
PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes) [1 year]
Blood pressure < 140 mm/Hg (<135/85 mm/Hg for for patients with diabetes mellitus)
LDL < 1.4 mmol/L [1 year]
Low density lipoprotein< 1.4 mmol/L
Not smoking [1 year]
Not smoking
Decrease in overweight [1 year]
Decrease in overweight
Aspirin or other antiplatelet or anticoagulant [1 year]
Adherence to aspirin or other antiplatelet or anticoagulant
Adherence to prescribed medication [1 year]
Adherence to prescribed at discharge medication
Hospitalization [1 year]
Hospitalization for cardiac reasons

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent
Age ≥ 40 years
PCI with coronary artery stenting for ACS
Angiographic success PCI

Exclusion Criteria:

Patients with cancer
Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA)
Severe valvular heart disease or Prosthetic heart valves.
Severe forms of CKD (GFR<30mL/min)
Planned staged revascularization during the next 12 months
Planned surgery within the next 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen		Russian Federation	625026

Sponsors and Collaborators

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

Principal Investigator: Ivan S Bessonov, MD, PhD, Tyumen Cardiology Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomsk National Research Medical Center of the Russian Academy of Sciences

ClinicalTrials.gov Identifier:

NCT04485754

Other Study ID Numbers:

TeleFU

First Posted:

Jul 24, 2020

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences

Telemedicine follow-up visit

Post-ACS rehabilitation

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Study Results

No Results Posted as of Apr 27, 2022